FDA.reportPublic FDA data

Vacuette

Primary DI
29120017576352
Brand
Vacuette
Company
Greiner Bio-One GmbH
Model
456002CA
Catalog number
456002CA
Device description
VACUETTE® TUBE 6 ml K2E K2EDTA 13x100 lavender cap-black ring, special label, non-ridged, USA
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKATubes, vials, systems, serum separators, blood collection
PJEBlood/plasma collection device for DNA testing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2
PJEBlood/Plasma Collection Device For Dna TestingClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK030032000
BK040018000
K014104000
K971236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK030032000
BK040018000
K014104000VACUETTE EDTA K2 TUBESGreiner Vacuette North America, Inc.2002-02-01PJE
K971236000GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc.1997-05-12JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
39120017576359PackageGS124In Commercial Distribution
29120017576352PrimaryGS10
19120017576355Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3912001757635939120017576359
2912001757635229120017576352
1912001757635519120017576355

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, K2EDTAA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening)]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
303639066
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19120126131421VACUETTE4530494530492026-01-26
19120126131407VACUETTE4530474530472026-01-26
19120126131414VACUETTE4530484530482026-01-26
19120126131469VACUETTE4530464530462026-01-26
29120126131404VACUETTE4530474530472026-01-26
29120126131411VACUETTE4530484530482026-01-26
29120126131428VACUETTE4530494530492026-01-26
29120126131466VACUETTE4530464530462026-01-26
29120017577656Vacuette4588154588152020-09-24
19120126131452VACUETTE4530454530452025-04-02
29120126131459VACUETTE4530454530452025-04-02
29120049209310Vacuette4560084560082025-03-25
29120049209327Vacuette4550244550242025-03-25
29120049209334Vacuette4550234550232025-03-25
39120049209317Vacuette4560084560082025-03-25
39120049209324Vacuette4550244550242025-03-25
39120049209331Vacuette4550234550232025-03-25
19120126131001VACUETTE7243257243252024-07-23
29120126131008VACUETTE7243257243252024-07-23
29120049204605Vacuette455232P455232P2016-09-23

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